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Is a 97.9% result from Medutest comparable to 98.8% from Janoshik?

Asked 3 Feb 2025Modified 16 months agoViewed 46k times
34

Setup, so nobody has to ask: 97.9% · Medutest · 98.8% · Janoshik.

Both of these get recommended confidently by different people, which suggests neither is obviously right.

My constraints are cost, measurement resolution and how much handling I am prepared to do — in roughly that order.

Is there a defensible reason to prefer one, or is this a coin flip?

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AF
askedayo_fadipe9.4k163 Feb 2025

5 Answers

Accepted answer first, then by votes
82

Accepted answer

97.9 and 98.8 are 0.9 percentage points apart, which sounds small until you restate it as impurity. Medutest is leaving 2.1 per cent of the detected area unassigned and Janoshik 1.2 per cent — a factor of 1.75 between them. The impurity fraction is the quantity that moves when a method changes, and it is the one worth arguing about; the headline is just its complement. Comparable means same column chemistry, same gradient slope, same detection wavelength, same integration convention. Until you have those four from both laboratories, 97.9 and 98.8 are two measurements of slightly different quantities that happen to share a unit.

To be exact about it, the single most important distinction is between what purity measures — the fraction of detected material that is your target — and what you actually want to know — how much of the material in the vial is your target.

The fraction of your main peak that is actually your target versus isomers, fragments or related sequences is invisible without complementary identity testing.

Reconciling gross mass to label claim

ComponentTypical shareCounted in purity?Counted in content?
Target peptide88–94 %Yes, as main peakYes
Related impurities1–3 %Yes, as other peaksNo
Counter-ion (TFA or acetate)2–8 %NoNo
Residual water2–6 %NoNo
Bulking agent, if present0–40 %NoNo

Gradient slope controls resolution, and gentler slopes resolve co-eluting impurities into separate peaks — so the better method reports the worse purity number.

The ICH Q3A impurity thresholds and the relevant pharmacopoeial chapters all specify method validation requirements that almost no research-grade certificate claims to meet.

One qualification: achieving purity above roughly 98 per cent on a 30-residue peptide is fighting the chemistry of synthesis, not the quality of the purification.

If you are ranking vendors, specify a method and have all samples tested at the same place.

edited 26 Mar 2025 by mz_4113 — clarified the distinction between purity and content

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M4
answered · acceptedmz_4113101k35828 Feb 2025
This should be linked from the help pages. – v_ramaswamy 5 months ago
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73

Start from what the detector sees, because that tells you what the number means.

Retention time is sequence-specific and method-specific, so comparing your result to a supplier value using a different method is meaningless without method documentation.

The relevant detail is that mobile phase additive choice affects ionisation and peak shape — TFA gives sharp peaks but suppresses mass spectrometry signal, formic acid gives worse peaks but preserves signal.

The Arrhenius relationship for peptide degradation is the basis of accelerated stability testing and also governs how quickly methods drift with temperature.

The limitation is that single-digit micro-impurities become invisible at typical reporting thresholds, so "no impurities detected" means "none above one in two thousand."

The practical summary: ask for the chromatogram and the method, and ignore the headline number until you have both.

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AL
answereda_lindgren58k24817 Feb 2025
3I would gently push back on the second point — inter-laboratory spread is wider than stated. – n_takahashi 3 months ago
2The distinction between purity and content cannot be repeated often enough here. – anouk_desmet 36 days ago
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38

In practice, understanding purity requires separating the chemistry from the method from the reporting convention, and the three are not independent.

Integration of the shoulder — whether you use perpendicular drop or tangent skim — determines what area gets assigned to the main peak versus the impurity table.

Specifically, detection wavelength matters because 214 nm sees the peptide backbone while 280 nm sees only aromatic side chains — so truncation impurities lacking a tryptophan are invisible at 280 nm.

Published side-by-side method comparisons show that a two-point difference in purity on the same vial is easily explained by method choice alone.

Compare purity within a single laboratory on the same method, never across laboratories.

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HL
answeredharriet_lonsdale35k13811 Mar 2025
The impurity table is the part I now read first, and this explains why. – orla_ferriter 5 months ago
Adding for future readers: the certificate should carry the lot number, not just a batch code. – imani_dube 7 months ago
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30

Purity is a method-dependent figure, and that is not a limitation of the measurement, it is a property of what the measurement actually answers.

Mass on column affects detector linearity and peak overlap — overloading broadens peaks and hides neighbours, while underloading improves resolution but loses sensitivity.

Inter-laboratory studies on identical peptide material routinely find half-a-per-cent to a full-per-cent spreads in reported purity on the same sample.

If you only pay for one test, pay for quantified content. Purity is the number everyone quotes and content is the number that changes what you do.

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DB
answeredDr_Signe_Baldursdottir29k2722 Mar 2025
23

Identity and purity are orthogonal, and a high purity says almost nothing about whether the peak is actually what you think it is.

Buffer versus acid in the mobile phase changes the ionisation state of basic and acidic residues, shifting retention and selectivity — same vial, potentially different separation.

In practice: ask for the chromatogram, check the method section, check the lot number against the vial, and set your accept threshold before you see the result rather than after.

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SK
answereds_kalniete57k382 Apr 2025

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